CE mark for CoreValve Evolut Pro

31st July 2017

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CoreValve Evolut Pro

Medtronic has received the CE mark for its CoreValve Evolut Pro valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. A press release reports that clinical data for the valve was presented at the American College of Cardiology annual Scientific Session (17–19 March, Washington, DC, USA) and showed high survival, low rates of stroke, minimal paravalvular leak and excellent haemodynamics.

According to the press release, the Evolut Pro device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.

The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3%) and low rates of disabling stroke (1.7%). The Evolut Proi valve also showed strong haemodynamic performance with large aortic valve areas (2.0± 0.5cm2) and mean gradients in the single digits (6.4± 2.1mmHg) at 30 days. The majority of study patients (72.4%) experienced no/trace paravalvular leak and no incidents of moderate or severe paravalvular leak were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10%.

Built on the proven platform of the recapturable CoreValve Evolut R System, the press release notes, the Evolut Pro valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent haemodynamic performance.

Nicolas M Van Mieghem (Erasmus Medical Center in Rotterdam, The Netherlands), says: “The Evolut Pro valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates with its ease-of-use and deliverability, the Evolut PRO valve will bring TAVI practice to a higher level, and I look forward to seeing it utilised in patients across Europe.”